PROLENE M8703Recalls & reported problems

Summary

The FDA's MAUDE database contains 70 adverse event reports that list this exact device (DI 10705031045781), received between Apr 3, 2019 and Sep 29, 2026 — classified as 70 malfunctions.

The most frequently reported specific device problem is “Material Separation” (35 reports).

21 other recalls cover devices cleared under the same FDA submission (K133356); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 70 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Material Separation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50934185 ↗
• MalfunctionMay 29, 2026Break; Material Frayed

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CORONARY ARTERY BYPASS GRAFT PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED TO THE SALES REP THAT DURING A CORONARY ARTERY BYPASS GRAFT PROCEDURE, THE SUTURE BROKE TWICE DURING SUTURING. NO PATIENT CONSEQUENCES WERE REPORTED. THE DEVICE IS NOT BEING RETURNED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25330760 ↗
• MalfunctionMar 2, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CABG PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. THE NEEDLE PULLED OFF. DURING THE PROCEDURE, THE SURGEON TRIED TO TIE THE SUTURE AFTER PASSAGE AND SIX DIFFERENT STRANDS BROKE DURING TYING. IT DELAYED THE PROCEDURE AROUND 15-20 MINUTES AND AFFECTED THE QUALITY OF THE ANASTOMOSIS. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24490378 ↗
• MalfunctionMar 2, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CABG PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. THE NEEDLE PULLED OFF. DURING THE PROCEDURE, THE SURGEON TRIED TO TIE THE SUTURE AFTER PASSAGE AND SIX DIFFERENT STRANDS BROKE DURING TYING. IT DELAYED THE PROCEDURE AROUND 15-20 MINUTES AND AFFECTED THE QUALITY OF THE ANASTOMOSIS. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24490305 ↗
• MalfunctionMar 2, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CABG PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. THE NEEDLE PULLED OFF. DURING THE PROCEDURE, THE SURGEON TRIED TO TIE THE SUTURE AFTER PASSAGE AND SIX DIFFERENT STRANDS BROKE DURING TYING. IT DELAYED THE PROCEDURE AROUND 15-20 MINUTES AND AFFECTED THE QUALITY OF THE ANASTOMOSIS. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24490275 ↗
• MalfunctionMar 2, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CABG PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. THE NEEDLE PULLED OFF. DURING THE PROCEDURE, THE SURGEON TRIED TO TIE THE SUTURE AFTER PASSAGE AND SIX DIFFERENT STRANDS BROKE DURING TYING. IT DELAYED THE PROCEDURE AROUND 15-20 MINUTES AND AFFECTED THE QUALITY OF THE ANASTOMOSIS. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24490202 ↗
• MalfunctionMar 2, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CABG PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. THE NEEDLE PULLED OFF. DURING THE PROCEDURE, THE SURGEON TRIED TO TIE THE SUTURE AFTER PASSAGE AND SIX DIFFERENT STRANDS BROKE DURING TYING. IT DELAYED THE PROCEDURE AROUND 15-20 MINUTES AND AFFECTED THE QUALITY OF THE ANASTOMOSIS. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24490192 ↗
• MalfunctionMar 2, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CABG PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. THE NEEDLE PULLED OFF. DURING THE PROCEDURE, THE SURGEON TRIED TO TIE THE SUTURE AFTER PASSAGE AND SIX DIFFERENT STRANDS BROKE DURING TYING. IT DELAYED THE PROCEDURE AROUND 15-20 MINUTES AND AFFECTED THE QUALITY OF THE ANASTOMOSIS. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24490176 ↗
• MalfunctionDec 3, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED TO THE DL BY THE SALES REP THAT THE 7-0 PROLINE BV-1 MULTIPASS NEEDLE THAT SUTURES KEPT BREAKING DURING SURGERY. THE 5-0 PROLINE C-1 NEEDLE ALSO CONTINUED TO BREAK. THERE WAS NO ADVERSE IMPACT ON PATIENT/USER REPORTED. DEVICES ARE AVAILABLE FOR RETURN. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23704725 ↗
• MalfunctionDec 3, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED TO THE DL BY THE SALES REP THAT THE 7-0 PROLINE BV-1 MULTIPASS NEEDLE THAT SUTURES KEPT BREAKING DURING SURGERY. THE 5-0 PROLINE C-1 NEEDLE ALSO CONTINUED TO BREAK. THERE WAS NO ADVERSE IMPACT ON PATIENT/USER REPORTED. DEVICES ARE AVAILABLE FOR RETURN. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23704716 ↗
• MalfunctionDec 3, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED TO THE DL BY THE SALES REP THAT THE 7-0 PROLINE BV-1 MULTIPASS NEEDLE THAT SUTURES KEPT BREAKING DURING SURGERY. THE 5-0 PROLINE C-1 NEEDLE ALSO CONTINUED TO BREAK. THERE WAS NO ADVERSE IMPACT ON PATIENT/USER REPORTED. DEVICES ARE AVAILABLE FOR RETURN. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23704711 ↗
• MalfunctionDec 3, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED TO THE DL BY THE SALES REP THAT THE 7-0 PROLINE BV-1 MULTIPASS NEEDLE THAT SUTURES KEPT BREAKING DURING SURGERY. THE 5-0 PROLINE C-1 NEEDLE ALSO CONTINUED TO BREAK. THERE WAS NO ADVERSE IMPACT ON PATIENT/USER REPORTED. DEVICES ARE AVAILABLE FOR RETURN. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23704688 ↗
• MalfunctionDec 3, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED TO THE DL BY THE SALES REP THAT THE 7-0 PROLINE BV-1 MULTIPASS NEEDLE THAT SUTURES KEPT BREAKING DURING SURGERY. THE 5-0 PROLINE C-1 NEEDLE ALSO CONTINUED TO BREAK. THERE WAS NO ADVERSE IMPACT ON PATIENT/USER REPORTED. DEVICES ARE AVAILABLE FOR RETURN. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23704684 ↗
• MalfunctionOct 29, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED TO THE DL BY THE SALES REP THAT THE 7-0 PROLINE BV-1 MULTIPASS NEEDLE THAT SUTURES KEPT BREAKING DURING SURGERY. THE 5-0 PROLINE C-1 NEEDLE ALSO CONTINUED TO BREAK. THERE WAS NO ADVERSE IMPACT ON PATIENT/USER REPORTED. DEVICES ARE AVAILABLE FOR RETURN. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23413890 ↗
• MalfunctionJul 8, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED THAT THE SURGEON STATED THAT THE NEEDLE WILL FELL OUT THE SWAGE WITHOUT FORCE. ADVERSE IMPACT PATIENT/USER: NO. DEVICE IS AVAILABLE FOR RETURN. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22437269 ↗
• MalfunctionMay 6, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED TO THE DL BY SALES REP THAT NEEDLE FALLS OFF OF THE SUTURE. NO ADVERSE IMPACT PATIENT/USER WAS REPORTED. DEVICE IS AVAILABLE FOR RETURN. THERE WERE NO ADVERSE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21971006 ↗
• MalfunctionApr 28, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED THAT THE SURGEON WHO STATED HE HAD A 7-0 DISINTEGRATE ON A DISTAL. HE HAD A COMPLAINT ON A 8-0 MONTHS AGO. HE¿S SINCE BEEN USING 7-0 AND HE NOTIFIED ME YESTERDAY OF HIS SIMILAR EXPERIENCE WITH THE 7-0. HIS COLLEAGUES WERE NOT USING THE 8-0 AT THE TIME. THEY ARE CURRENTLY USING 7-0. I HAVE NOT HAD ANY FEEDBACK FROM HIS COLLEAGUES. THERE WERE NO A PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21918569 ↗
• MalfunctionApr 28, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED THAT THE SURGEON WHO STATED HE HAD A 7-0 DISINTEGRATE ON A DISTAL. SURGEON IS WILLING TO HAVE A RAPID RESPONSE CALL TO DISCUSS. THERE WAS NO PATIENT CONSEQUENCE REPORTED. THE COMPLAINT IS INTRA OP. THE SURGEON HAS STATED PROLENE IS DEGRADING AS HE IS TYING HIS KNOTS ON HIS DISTAL ANASTOMOSIS. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21918488 ↗
• MalfunctionJan 7, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED THAT THE SURGEONS SAID THE SUTURES WERE BREAKING FAR TOO EASILY. THEY SWITCHED TO SINGLE SUTURES AND THE SUTURES DID NOT CONTINUE TO BREAK. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21095271 ↗
• MalfunctionJan 7, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED THAT THE 2ND SURGEON HAD ISSUES WITH THE MULTIPACK OF THE SUTURE BREAKING, SWITCHED TO INDIVIDUAL SUTURE AND HAD NO MORE ISSUES W/ BREAKING, THEY PULLED 3 BOXES OF THIS LOT THEY HAD, DUE TO THE COMPLAINTS SURGEONS WON'T USE THEM FOR FEAR OF BREAKING AND CAUSING CONSEQUENCES TO THE PATIENT. THERE WERE NO PATIENT CONSEQUENCE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21095232 ↗
• MalfunctionJan 6, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, SURGEONS AND NURSING TEAM REQUESTED TO PULL THE REMAINING LOTS OF 102TPM - 7-0 M8703 MULTIPACK SUTURES DUE TO 2 PRIOR INCIDENTS OF SUTURES BREAKING ON THEM. (CARDIAC SURGEONS) THERE WERE NO ADVERSE CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21084802 ↗
• MalfunctionJan 6, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, SURGEONS AND NURSING TEAM REQUESTED TO PULL THE REMAINING LOTS OF 102TPM - 7-0 M8703 MULTIPACK SUTURES DUE TO 2 PRIOR INCIDENTS OF SUTURES BREAKING ON THEM. (CARDIAC SURGEONS) THERE WERE NO ADVERSE CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21084792 ↗
• MalfunctionJan 6, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, SURGEONS AND NURSING TEAM REQUESTED TO PULL THE REMAINING LOTS OF 102TPM - 7-0 M8703 MULTIPACK SUTURES DUE TO 2 PRIOR INCIDENTS OF SUTURES BREAKING ON THEM. (CARDIAC SURGEONS) THERE WERE NO ADVERSE CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21084752 ↗
• MalfunctionNov 27, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CABG PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. WHILE SOWING DISTAL ANASTOMOSIS, THE NEEDLE KEPT POPPING OFF THE SUTURE. THEY USED A NEW SUTURE FROM A DIFFERENT LOT NUMBER TO COMPLETE THE CASE WITHOUT PATIENT HARM. THE NEEDLE DID NOT FALL INTO THE PATIENT. THE NEEDLE STAYED IN THE NEEDLE HOLDER. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20792635 ↗
• MalfunctionNov 27, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CABG PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. WHILE SOWING DISTAL ANASTOMOSIS, THE NEEDLE KEPT POPPING OFF THE SUTURE. THEY USED A NEW SUTURE FROM A DIFFERENT LOT NUMBER TO COMPLETE THE CASE WITHOUT PATIENT HARM. THE NEEDLE DID NOT FALL INTO THE PATIENT. THE NEEDLE STAYED IN THE NEEDLE HOLDER. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20791781 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K133356. One submission often covers many models, so check the product and lot details in each record.

• Z-1515-2025 · Mar 7, 2025 · Open, Classified
  PROLENE BLU 18IN(45CM) USP6-0(M0.7) S/A P-1 PRM
• Z-1096-2025 · Dec 20, 2024 · Open, Classified
  PROLENE Polypropylene Suture, REF: EH7585H, 8706H, 8833H, 8963H, 8935H PROLENE Suture is indicated for use in general soft tissue approximation and/or ligation, including use in ca
• Z-2455-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 30"(75CM) 8-0 BLUE, D8292
• Z-2466-2018 · May 7, 2018 · Terminated
  PRONOVA SUTURE BLUE 122CM M1.5, D10189
• Z-2454-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE BLUE 4X18"5/0 DA RB-2 +PLG, D7879
• Z-2465-2018 · May 7, 2018 · Terminated
  PRONOVA SUTURE BLUE MONO POLY - SH-1 Taperpoint 1/2C, D10027
• Z-2462-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 36"(90CM) 3-0 BLU, D9844
• Z-2457-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 24"(60CM) 6-0 BLUE, D8688
• Z-2452-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 30"(75CM) 4-0 BLUE, D7748
• Z-2453-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 36"(90CM) 4-0 BLUE, D7768
• Z-2463-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE MONO BLUE BV1755 Taperpoint 3/8C, D9995
• Z-2456-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE 30"(75CM) 6-0 BLUE, D8647
• Z-2449-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE BLUE 4X90CM M1.5 USP 4/0 DA RB-1 +P, D5981
• Z-2448-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE MONO BLUE - BV1755 Taper Point 3/8C, D10031
• Z-2464-2018 · May 7, 2018 · Terminated
  PROLENE SUTURE BLUE 18" 7-0 D/A BV-1, DC631

…and 6 more.